Insulated Implantable Electrical Curcuit

ABSTRACT

The invention is directed to a method of making an implantable insulated electrical circuit that utilizes polyparaxylylene, preferably as Parylene, a known polymer that has excellent living tissue implant characteristics, to provide for chronic implantation of conductive electrical devices, such as stimulators and sensors. The device is thin, flexible, electrically insulated, and stable after long exposure to living tissue. Layers of Parylene may be combined with layers of a polymer, such as polyimide, to yield greater design flexibility in the circuit. Multiple electrical conduction layers may be stacked in the circuit to increase packing density.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No. 11/441,993, for Insulated Implantable Electrical Circuit, filed May 26, 2006, which is a continuation of U.S. patent application Ser. No. 10/638,989, for Insulated Implantable Electrical Circuit, filed Aug. 11, 2003, which claims the benefit of U.S. provisional Application No. 60/402,591 filed on Aug. 9, 2002, the disclosures of which are hereby incorporated by reference.

FEDERALLY SPONSORED RESEARCH

This invention was made with government support under grant No. R24EY12893-01, awarded by the National Institutes of Health. The government has certain rights in the invention.

FIELD OF THE INVENTION

This invention relates to implantable medical devices, especially implantable cables and electrode arrays for stimulation, recording and interconnection.

BACKGROUND OF THE INVENTION

Arrays of electrodes for neural stimulation are commonly used for a variety of purposes. Some examples include U.S. Pat. No. 3,699,970 to Brindley, which describes an array of cortical electrodes for visual stimulation. Each electrode is attached to a separate inductive coil for signal and power. U.S. Pat. No. 4,573,481 to Bullara describes a helical electrode to be wrapped around an individual nerve fiber. U.S. Pat. No. 4,837,049 to Byers describes spike electrodes for neural stimulation. Each spike electrode pierces neural tissue for better electrical contact. U.S. Pat. No. 5,215,088 to Norman describes an array of spike electrodes for cortical stimulation. U.S. Pat. No. 5,109,844 to de Juan describes a flat electrode array placed against the retina for visual stimulation. U.S. Pat. No. 5,935,155 to Humayun describes a retinal prosthesis for use with a flat retinal array.

Packaging of a biomedical device intended for implantation in the eye, and more specifically for physical contact with the retina, presents a unique interconnection challenge. The consistency of the retina is comparable to that of wet tissue paper and the biological media inside the eye is a corrosive saline liquid environment.

Thus, the device to be placed against the retina, in addition to being comprised of biocompatible, electrochemically stable materials, must appropriately conform to the curvature of the eye, being sufficiently flexible and gentle in contact with the retina to avoid tissue damage, as discussed by Schneider, et al. [see A. Schneider, T. Stieglitz, W. Haberer, H. Beutel, and J.-Uwe Meyer, “Flexible Interconnects for Biomedical Microsystems Assembly,” IMAPS Conference, Jan. 31, 2001.] It is also desirable that this device, an electrode array, provides a maximum density of stimulation electrodes. A commonly accepted design for an electrode array is a very thin, flexible circuit cable. It is possible to fabricate a suitable electrode array using discrete wires, but with this approach, a high number of stimulation electrodes cannot be achieved without sacrificing cable flexibility (to a maximum of about 16 electrodes).

Known insulators for implanted electrical circuits include polyimide and silicone dielectrics. They have limited lives once implanted. The polyimide slowly degrades upon exposure to the living tissue and allows water to reach the electrical conductor, eventually leading to at least partial electric current leakage.

Known techniques for implanted electrical circuits do not result in a hermetic package that is suitable for chronic implantation in living tissue. Therefore, it is desired to have an insulated electrical conductor that ensures that the electronic package will function for long-term implant applications in living tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a cross-sectional view of an implantable electrical circuit.

FIG. 2 illustrates a cross-sectional view of an alternate implantable electrical circuit.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The preferred embodiment is an implantable insulated electrical circuit for electrical transmission within living organisms. These assemblies provide electrical conduction, isolation of the electrical conductors from the environment in the living tissue and from each other, and mechanical support for the electrical conductor. Electrical device assemblies that are commonly used for stimulation and or recording within the body benefit from the invention. Neural stimulators or sensors are of particular interest, including retinal electrode arrays. The implantable insulated electrical conductors may also be used to connect discrete components of an implanted medical device, permitting the transmission of electrical signals, power, as well as providing mechanical connection. Key attributes include good electrical insulation properties, low moisture absorption, appropriate mechanical characteristics and ease of fabrication.

Polyparaxylylene is a known polymer that has excellent implant characteristics. One example, Parylene, manufactured by Specialty Coating Systems (SCS), a division of Cookson Electronic Equipment Group, located in Indianapolis, Indiana, is a preferred material. Parylene is available in various forms, such as Parylene C, Parylene D, and Parylene N, each having different properties. The preferred form is Parylene C, although it is recognized that many forms of polyparaxylylene may exist or may be developed that are suitable for this application.

The use of Parylene was mentioned, but not pursued, by Sonn and Feist. [see M. Sonn and W. M. Feist, “A Prototype Flexible Microelectrode Array for Implant-Prosthesis Applications,” Medical and Biological Engineering, 778-791, November 1974.] Stieglitz, et al. published fabrication details of similar items manufactured using polyimide. [see T. Stieglitz, H. Beutel, M. Schuettler, and J.-U. Meyer, “Micromachined, Polyimide-Based Devices for Flexible Neural Interfaces,” Biomedical Microdevices, 2:4, 283-294, 2000.] Ganesh wrote a thesis on ribbon cables for neural recording and stimulation using polyimide [see B. Ganesh, “A Polyimide Ribbon Cable for Neural Recording and Stimulation Systems,” Thesis, University of Utah, March 1998.] Parylene is widely used as an electrical insulating and barrier material in commercial electronic devices. It is well known to use Parylene as a conformal coating on printed circuit boards. While discrete wires have been coated with Parylene for implantation, such as with cochlear implants, the application of Parylene as an electrical insulator for implantable electrical circuits, as embodied by this invention, is unknown to the inventors.

The moisture vapor transmission rates compare favorably with those of other conformal coating materials. The rate for Parylene C is superior to almost all polymeric materials. The Parylenes resist room temperature chemical attack is and are insoluble in organic solvents up to 150° C. Parylene C can be dissolved in chloro-napthalene at 175° C., and Parylene N is soluble at the solvent's boiling point (265° C.). The thermal properties are given in Table 1 and the electrical properties are given in Table 2.

TABLE 1 Parylene Thermal Properties (2) Parylene Parylene Parylene Epoxides Silicones Urethanes Properties Method N C D (1) (1) (1) Melting Point (° C.) 1 420 290 380 cured cured ~170 T5 Point (° C.) 1 160 125 125 110 ~125 ~30 (modulus = (10⁵ psi) T4 Point (° C.) 1 >300 240 240 120 ~80 0 (modulus = (10⁴ psi) Linear Coefficient — 6.9 3.5 3-8 4.5-6.5 25-30 10-20 of Expansion at 25° C. (×10⁵, (° C.)⁻¹) Thermal 2 3.0 2.0 — 4-5 3.5-7.5 5.0 Conductivity at 25° C. (10⁻⁴ cal/(cm · s · ° C.)) Specific Heat — 0.20 0.17 — 0.25 — 0.42 at 20° C. (cal/g ° C.) Test Methods 1 Taken from Secant modulus-temperature curve 2 ASTM C 177 (1) Properties and methods as reported in Modern Plastics Encyclopedia, issue for 1968, Vol. 45/No. 1A, McGraw Hill, New York, 1967 (2) After Specialty Coating Systems, Indianapolis, IN.

TABLE 2 Parylene Electrical Properties (3) Parylene Parylene Parylene Epoxides Silicones Urethanes Properties (1) N C D (2) (2) (2) Dielectric Strength, dc 7,000      5,600     5,500    volts/mil short time, 1 mil films^(a) Corrected to ⅛ inch 630    500    490    400-500 550    450-500 Volume Resistivity 1.4 × 10¹⁷ 8.8 × 10¹⁶ 1.2 × 10¹⁷  10¹²-10¹⁷ 10¹⁵ 10¹¹-10¹⁵ ohm-cm, 23° C., 50% RH^(b) Surface Resistivity, 10¹³      10¹⁴    10¹⁶    10¹³ 10¹³ 10¹⁴ ohms, 23° C., 50% RH^(b) Dielectric Constant^(c) 60 Hz 2.65  3.15  2.84   3.5-5.0 2.7-3.1 5.3-7.8  1 KHz 2.65  3.10  2.82   3.5-4.5 2.6-2.7 5.4-7.6  1 MHz 2.65  2.95  2.80   3.3-4.0 2.6-2.7 4.2-5.2 Dissipation Factor 60 Hz 0.0002 0.020 0.004 0.002-0.01 0.001-0.007 0.015-0.05   1 KHz 0.0002 0.019 0.003 0.002-0.02 0.001-0.005 0.04-0.06  1 MHz 0.0006 0.013 0.002  0.03-0.05 0.001-0.002 0.05-0.07 ^(a)ASTM D 149 ^(b)ASTM D 257, 1 in² mercury electrodes ^(c)ASTM D 150, 1 in² (1) Properties measured on Parylene films, 0.001 in thick. (2) Properties and methods as reported in Modern Plastics Encyclopedia, issue for 1968, vol. 45, No. 1A, McGraw Hill, NY, 1967. (3) After Specialty Coating Systems, Indianapolis, IN.

A cross-sectional view of a preferred embodiment of the invention is presented in FIG. 1. An electrical circuit 1 is shown generally being formed on a rigid substrate 2. The substrate 2 may be selected from glass or ceramic, such as alumina or silicon. Substrate 2 is preferably comprised of glass.

A first Parylene layer 4 is deposited on the substrate 2 from a vapor phase that is produced by known techniques, such as thermal decomposition. It is known that Parylene is the polymer “polyparaxylylene” and that any source of this material may be used to implement this invention. The inventors use the term Parylene, as is common in industry practice, to indicate the class of polyparaxylylene polymers.

An electrical conductor 6 is deposited by a known physical vapor deposition method, such as sputtering or evaporation. While the preferred embodiment is to an electrical conductor 6 that is comprised of one material, it is clear that the electrical conductor 6 may also be comprised of layers of several materials. Alternatively, the conductor 6 or combination thereof may be deposited by other known methods, such as direct write, plating, or electrophoresis. The electrical conductor 6 is patterned by known techniques, such as lift-off or etching. The electrical conductor 6 may be comprised of a single metal or in an alternate embodiment, from several metals that may be layered or alloyed, that are selected from a group of electrically conductive biocompatible materials having favorable electrochemical characteristics, such as titanium, platinum, gold, iridium, and their alloys. Multiple metals may be used in order to achieve desired characteristics. For example, adhesion and barrier layers are commonly used in electronics where individual metal layers are combined to yield a more functional circuit stack. These electrical conduction paths, traces, bond pads, and electrode sites are formed prior to depositing a second layer of Parylene 8 to the device. Typical thicknesses of each Parylene layer are in the range of 0.5 to 50 microns, and preferably are about 3 to 15 microns thick. An alternate embodiment uses metals that are not biocompatible, so long as they are completely encapsulated by the surrounding structural elements and thus do not contact living tissue.

In an alternate embodiment, non-biocompatible materials, such as chrome, silver, or copper may be used as the electrical conductor 6. The electrical conductor 6 is then coated with a biocompatible, hermetic coating in the exposed aperture 6 area. This coating is preferably titanium nitride, although in alternative embodiments it may be an electrically conductive biocompatible metal, such as titanium, platinum, gold, iridium, or their alloys. The Parylene layers cover and protect the rest of the electrical conductor 6.

Apertures 10 are patterned by known techniques, such as by dry etching or laser ablation, or by reactive ion etching. The apertures 10 permit electrical conduction to either tissue or a connected implanted device. The apertures 10 define an electrode area on the electrical conductor 6.

The rigid substrate 2 is removed by known techniques, such as mechanical separation or etching, where mechanical separation is the preferred technique.

As a further embodiment of the invention, adhesion between the first layer of Parylene 4 and the second layer of Parylene 8 is preferably improved by one or more of the following techniques:

(a) Silane application between Parylene layers.

(b) Chemical modification of the Parylene surface to create an energetic, a reactive, or an amorphous surface (Parylene is amorphous as deposited).

(c) Roughening of the Parylene surface.

(d) Thermal compression of the Parylene layers.

Techniques (b) and (c) can used to improve the metal to Parylene adhesion, if applied prior to metal deposition.

More than one electrical conductor 6 may be deposited adjacent to the Parylene. Additional metal layers may be deposited that are protected by additional Parylene layers, such that a multilayered higher density electrical circuit is achieved.

A further alternative embodiment, FIG. 2, of the invention preferably replaces the first layer of Parylene 4 with a polymer layer 111, which is preferably polyimide, such that beginning with the rigid substrate 102, the layers are, preferably, polymer layer 111 (polyimide)-electrical conductor 106-layer of Parylene 104. The polyimide is preferably applied as a liquid.

In an alternative embodiment, not illustrated, one applies a first polymer coating, preferably polyimide, prior to depositing the first Parylene layer, such that beginning with the rigid substrate, the layers are, polymer layer (preferably polyimide)-first Parylene layer-electrical conductor-second layer of Parylene.

In yet another embodiment, not illustrated, a polymer coating, preferably of polyimide is applied between the Parylene layer and the electrical conductor.

In further embodiments, not illustrated, a polymer coating, preferably of polyimide is deposited on either side of the second layer of Parylene, either in the presence or absence of a polymer coating on the first layer of Parylene.

Obviously, many modifications and variations of the present invention are possible in light of the above teachings. It is therefore to be understood that, within the scope of the appended claims, the invention may be practiced otherwise than as specifically described. 

We claim:
 1. A method of making an insulated flexible electrical circuit suitable for implantation in living tissue comprising: providing a substrate; depositing by vapor deposition a first polyparaxylylene layer, 0.5 to 50 microns thick; depositing an electrically conductive layer on the first polyparaxylylene layer; patterning the electrically conductive layer to form traces; depositing by vapor deposition a second polyparaxylylene layer, 0.5 to 50 micros thick, on the first polyparaxylylene layer and on the trace; forming at least one openings in the second polyparaxylylene layer that exposes the electrical conductor trace suitable for electrical communication with living tissue; and removing the first polyparaxylylene layer, the traces and the second polyparaxylylene layer from the substrate forming a free standing structure.
 2. The method according to claim 1, further comprising depositing at least one polymer layer between the first polyparaxylylene layer and the second polyparaxylylene layer.
 3. The method according to claim 3, wherein the polymer layer comprises polyimide.
 4. The method according to claim 1, further comprising depositing at least one polymer layer on the first polyparaxylylene layer or the second polyparaxylylene layer that is not located between the first polyparaxylylene layer and the second polyparaxylylene layer.
 5. The method according to claim 4, wherein the polymer layer comprises polyimide.
 6. The method according to claim 1, further comprising depositing a polymer layer between the first polyparaxylylene layer and the electrically conductive layer.
 7. The method according to claim 6, wherein the polymer layer comprises of polyimide.
 8. The method according to claim 1, wherein the traces are configured to stimulate nerves.
 9. The method according to claim 1, wherein the traces are configured to sense signals from nerves.
 10. The method according to claim 1, wherein the second polyparaxylylene layer further defines at least one electrode site configured to detect or transmit signals to living tissue.
 11. The method according to claim 1, wherein the traces comprise a biocompatible material.
 12. The method according to claim 11, wherein the biocompatible material is selected from the group consisting of titanium, platinum, gold, and iridium.
 13. The method according to claim 1, wherein the traces are at least partially coated with a biocompatible material.
 14. The method according to claim 13, wherein the biocompatible material comprises titanium nitride.
 15. The method according to claim 1, wherein a coating is deposited on the electrical conductor at the at least one aperture and is comprised of biocompatible titanium nitride.
 16. The method according to claim 1, further comprising depositing a coating on the trace at the at least one aperture.
 17. The method according to claim 16, wherein the coating is selected from the biocompatible metal group consisting of titanium, platinum, gold, iridium, or their alloys.
 18. The method according to claim 16, wherein the coating comprises titanium nitride, titanium, platinum, gold, iridium, or their alloys. 